CGTLive’s Weekly Rewind – April 8, 2022

Welcome to CGTLive’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

1. FDA Grants ASC618 Fast Track Designation for Hemophilia A

The gene therapy ASC618 has received European and US designations and opinions that could help expedite development for hemophilia A.

2. Bluebird Bio Slashes Workforce as It Awaits Key FDA Gene Therapy Decisions

The company will be cutting its workforce by 30% in order to extend its cash runway into 2023 as it awaits 2 key FDA decisions on betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).

3. FDA Approves Second-Line Axicabtagene Ciloleucel for LBCL

The FDA has approved second-line axicabtagene ciloleucel as a treatment for adult patients with large B-cell lymphoma following frontline chemoimmunotherapy.

4. UltraCAR-T Cell Therapy Wins Fast Track Designation in Acute Myeloid Leukemia

The investigational therapy leverages an advanced overnight nonviral gene delivery manufacturing process that may help it overcome existing treatment limitations.

5. Tumor-Infiltrating Lymphocyte Therapy Gets Positive FDA Feedback for Melanoma

Iovance Biotherapeutics has received positive feedback from the FDA regarding their proposed potency assay and cell co-culture assays for its upcoming Biologics License Application (BLA) for lifileucel (LN-144) for the potential treatment of metastatic melanoma.